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Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT04261777
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
b.e.imaging GmbH
Radboud University
Information provided by (Responsible Party):
Saving Patients' Lives Medical B.V.

Brief Summary:
This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastasis Prostatectomy Drug: Ferrotran® (Ferumoxtran-10) Phase 3

Detailed Description:

Potential patients for this study will be recruited by up to 10 centres specialised in prostate cancer. Study sites will be interdisciplinary, consisting of a uro-oncology sub-site, and a radiology sub-site with high-quality MRI, surgery and pathology. Study visits will be typically conducted at the recruiting sub-site, or as institutionally appropriate. Treatment visits for patients will be performed in the collaborating sub-site. Patients will be invited for study participation by the investigators in the context of specialised clinics. Interested patients will be provided with an information sheet and will undergo a detailed informed consent procedure prior to any study procedures. Recruitment will be continued until a sufficient number of patients have undergone Ferrotran® imaging and histopathological evaluation.

To compensate for an expected drop-out rate of 15% to 20%, recruitment will only be stopped as soon as at least 69 evaluable positive (patients positive) and at least 104 evaluable negative (patients negative) patients are available for analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SPL-01-001 Drug: Ferrotran® (Ferumoxtran-10)

Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min).

Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.

Other Name: Ferrotran Lyophilisate




Primary Outcome Measures :
  1. Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced). [ Time Frame: up to day 42 ]
    True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.


Secondary Outcome Measures :
  1. Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced). [ Time Frame: up to day 105 ]
  2. Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events) [ Time Frame: day 0 - day 105 ]
  3. Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI. [ Time Frame: up to day 105 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male with prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily given and written informed consent.
  2. Male ≥18 years of age.
  3. Histologically newly-confirmed adenocarcinoma of the prostate.
  4. Medium to high risk for lymph node metastasis, defined by either:

    1. PSA ≥10 ng/mL or
    2. Gleason-Score ≥7 or
    3. Stage cT2b or cT2c or T3 or T4
  5. Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
  6. Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.

Exclusion Criteria:

  1. Any contraindication to MRI, as per standard criteria.
  2. Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
  3. Known hypersensitivity to Ferrotran® or its components such as dextran.
  4. Known hypersensitivity to other parenteral iron products.
  5. Acute allergy, including drug allergies and allergic asthma.
  6. Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
  7. Presence of liver dysfunction.
  8. Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
  9. Simultaneous participation in any other clinical trial.
  10. Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
  11. Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
  12. Patients with acute SARS-CoV-2 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261777


Contacts
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Contact: Jürgen Feuerstein, Dr. +31 24 303 10 90 info@splmed.com
Contact: Volker Meyer, Dr. +49 351 21 444 0 info@abx-cro.com

Locations
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Germany
Charité - Universitätsklinikum Berlin Recruiting
Berlin, Germany, 10117
Vivantes Klinikum Am Urban Not yet recruiting
Berlin, Germany, 10967
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Universitätsklinikum Köln Not yet recruiting
Cologne, Germany, 50937
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Universitätsklinikum Essen Not yet recruiting
Essen, Germany, 45147
Universitätsklinikum Leipzig Not yet recruiting
Leipzig, Germany, 04103
Universitätsklinikum Schleswig-Holstein Lübeck Not yet recruiting
Lübeck, Germany, 23538
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek Not yet recruiting
Amsterdam, Netherlands, 1006
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525
Canisius-Wilhelmina Ziekenhuis Nijmegen Recruiting
Nijmegen, Netherlands, 6532
Switzerland
Inselspital-Universitätsspital Bern Recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
Saving Patients' Lives Medical B.V.
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
b.e.imaging GmbH
Radboud University
Investigators
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Study Chair: Jelle Barentsz, MD Radboud University
Publications:
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Responsible Party: Saving Patients' Lives Medical B.V.
ClinicalTrials.gov Identifier: NCT04261777    
Other Study ID Numbers: SPL-01-001
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saving Patients' Lives Medical B.V.:
SPL-01-001
ePLND
MRI
USPIO
MR lymphography
Ferrotran
Ultra-small superparamagnetic iron oxide
Nanoparticles
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases